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Could fasting boost breast cancer drugs? new study investigates

NCT ID NCT07624617

Knowledge-focused Sponsor: University of Minnesota Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 4 times

Summary

This study looks at whether a special fasting schedule (eating only dinner) can make PI3K inhibitor drugs work better against metastatic breast cancer. Researchers will check if patients can stick with the fasting plan and study blood samples to see how fasting affects cancer cells in the lab. Only 15 people will take part, and the goal is to gather early clues, not to prove a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
prolonged fasting (behavioral intervention)
What this could lead to
If successful, this could point toward a way to make existing cancer drugs work better by adding a fasting regimen.
What could go wrong
This is a very small, early-stage trial (15 people) that only measures biological markers, not patient outcomes. Fasting may be hard to tolerate and may not improve treatment effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥18 years * Histologically confirmed metastatic breast cancer * Menopausal or medically ovarian suppressed * Currently receiving capivasertib therapy (2 tablets twice daily, 4 days per week) * Stable on current capivasertib regimen for at least 2 weeks * an ECOG performance status of 0-1 * BMI ≥25kg/m2 * Able to provide informed consent * Willing to comply with study procedures including CGM wear, food tracking by mCC app and dietary modifications * Access to smartphone or tablet for mobile application use Exclusion Criteria: * Type 1 diabetes mellitus * Uncontrolled type 2 diabetes (HbA1c \>9.0%) * History of severe hypoglycemia * Eating disorders or contraindications to fasting * Pregnancy or breastfeeding * Significant gastrointestinal disorders affecting food absorption * Unable to fast for medical reasons * Concurrent participation in other dietary intervention studies * A history of significantly abnormal lab results within 4 weeks of consent date, such as hematologic (Hgb \< 10.0, platelets \< 100), hepatic (LFTs \> 2X nl), renal (Cr \> 1.5)

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

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